Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00003297
First received: November 1, 1999
Last updated: March 22, 2011
Last verified: September 2000
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with stage III or stage IV ovarian cancer that has not recurred or that has not responded to previous chemotherapy.


Condition Intervention Phase
Ovarian Cancer
Drug: mitoxantrone hydrochloride
Drug: thiotepa
Drug: topotecan hydrochloride
Procedure: peripheral blood stem cell transplantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I/II Study of High Dose Topotecan, Mitoxantrone and Thiotepa (TMT) Followed by Autologous Stem Cell Transplant in Patients With Recurrent Platinum Resistant Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Estimated Enrollment: 50
Study Start Date: December 1997
Study Completion Date: January 2001
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose and the dose limiting toxicities of topotecan, mitoxantrone, and thiotepa given in combination followed by autologous peripheral blood stem cell transplantation in patients with recurrent or refractory platinum resistant epithelial ovarian cancer. II. Determine the progression-free survival and overall survival of these patients after this therapy.

OUTLINE: This is a dose escalation study of topotecan. All patients have peripheral stem cells collected. Patients then receive topotecan according to an escalating dose schedule, and mitoxantrone and thiotepa on a fixed dose schedule. Patients receive topotecan by continuous infusion for 24 hours on days 1-3, mitoxantrone intravenously over 1 hour on days 1-3, and thiotepa intravenously over 4 hours on days 1-3, followed 48 hours later by infusion of their peripheral stem cells. Patients may receive a second course of chemotherapy and peripheral stem cell transplantation in the absence of disease progression and unacceptable toxicity. Dose escalation of topotecan continues in cohorts of 3-6 patients each until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity. Patients are followed every week for the first month, then every month for 6 months, every 3 months for 1 year, and then every 6 months.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV epithelial ovarian cancer that is refractory to platinum therapy or has relapsed within 12 months after platinum therapy Minimal residual disease by laparotomy Must have adequate number of peripheral stem cells collected No intraabdominal, pelvic disease, or other disease greater than 1 cm No brain metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2 times the upper limit of normal (ULN) Serum transaminases less than 2 times ULN Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: Cardiac ejection fraction at least 45% No active angina No uncontrolled hypertension Pulmonary: FEV1, vital capacity, and diffusion capacity greater than 50% of predicted Other: Not HIV positive No active hepatitis B or C infection Not pregnant No concurrent malignancy except basal cell or squamous cell carcinoma of the skin No serious medical conditions such as uncontrolled diabetes mellitus

PRIOR CONCURRENT THERAPY: Biologic therapy: No immunotherapy within the past 4 weeks No concurrent immunotherapy Chemotherapy: No chemotherapy within the past 4 weeks No mitomycin within the past 6 weeks No other concurrent chemotherapy No prior anthracycline therapy greater than 200 mg/m2 Endocrine therapy: Not specified Radiotherapy: No radiotherapy within the past 4 weeks No concurrent radiotherapy No prior radiotherapy to the whole abdomen Surgery: Prior surgery allowed

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003297

Locations
United States, District of Columbia
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Study Chair: Gary Spitzer, MD Lombardi Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: John Marshall, MD, Georgetown University
ClinicalTrials.gov Identifier: NCT00003297     History of Changes
Other Study ID Numbers: CDR0000066235, P30CA051008, GUMC-97342, NCI-G98-1414
Study First Received: November 1, 1999
Last Updated: March 22, 2011
Health Authority: United States: Federal Government

Keywords provided by Georgetown University:
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Topotecan
Mitoxantrone
Thiotepa
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Topoisomerase II Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on September 18, 2014